Events

Recall of IDS Urine BETA CrossLaps ELISA

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Immunodiagnostics Systems Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    62968
  • Event Risk Class
    Class 2
  • Event Number
    Z-0039-2013
  • Event Initiated Date
    2012-08-10
  • Event Date Posted
    2012-10-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112204
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    N/A - Product Code JMM
  • Reason
    It has been noted by staff at ids inc. that stock of the affected products held at ids inc. are labeled with ivd labels although they are not registered for sale as ivds in the united states. the products should have been labeled as research use only or investigational use only dependent on their usage.
  • Action
    Immunodiagnostics Systems sent Customer notification letters via email and notified customers of the recall. The notification included the reason for recall, product information with codes, lot number, manufacturing/distribution date, and exp date. The notification included instructions to customers: Actions to be taken by the customer: Customers should complete the attached Recall and Acknowledgement Form and take the following actions: 1) Check your stock for the products included within the scope of the recall. Cease use and distribution and quarantine all affected product lots immediately. 2) Complete the enclosed Recall & Acknowledgement Form and immediately fax back to Immunodiagnostic Systems. This will allow us to document your receipt of this letter and the amount of product you have on hand for return. 3) Return any affected product freight collect, along with the original completed Recall & Acknowledgement Form to your local IDS office. Contact information was also provided. For questions regarding this recall call +44 (191) 5195212.

Device

IDS Urine BETA CrossLaps ELISA
  • Model / Serial
    Lot 14541, EXP Nov 2012
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including NY, CA, ME and CT.
  • Product Description
    IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. || The Urine BETA CrossLaps¿ ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in human urine. The Urine BETA CrossLaps¿ ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption as an aid in A. Monitoring bone resorption changes of 1) Anti-resorptive therapies in postmenopausal women: a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies B. Predicting skeletal response (Bone Mineral Density) in postmenopausal women undergoing anti-resorptive therapies a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies
  • Manufacturer
    Immunodiagnostics Systems Ltd

Manufacturer

Immunodiagnostics Systems Ltd
  • Manufacturer Address
    Immunodiagnostics Systems Ltd, 10 Didcot Way Bolden Business Park, Boldon Tyne & Wear United Kingdom
  • Source
    USFDA